The invention relates to a method and an apparatus for the transport of one or more fluid substances between respective reservoirs and predetermined sites in or on the body of an animal.
In particular, the invention enables one or more substances to be delivered to, and/or collected from, respective sites in or on the body of an animal. Such sites include internal sites, such as natural body cavities, e.g. vaginal, nasal and buccal cavities.
The method and apparatus is particularly suitable for unsupervised substance transport over an extended period on ambulatory animals.
The invention is suited to use on an animal and particularly to domestic cattle or other quadrupeds such as pigs, goats, sheep or deer. The invention could be adapted for use with birds. In a particular embodiment, it relates to an apparatus attached to a cow for the delivery of a substance such as a therapeutic agent, to the cow.
Substance delivery devices are known for administration of substances to the human body.
U.S. Pat. No. 3,547,322 discloses an apparatus for intravenous administration, to a human patient, of a fluid from a container supported by a harness and secured externally to the body of the patient. The apparatus is said to allow the patient to move about, or be moved about, during such intravenous administion. The apparatus is unwieldy and totally unsuited for unsupervised field use on freely ambulatory animals.
U.S. Pat. No. 5,728,070 discloses a portable medication dispenser system in which a harness, e.g. a waist belt and an optional shoulder strap, externally worn by a human patient supports a container holding the medication, e.g. in a pocket at one location, and a pump at another location. Tubing interconnects the container, the pump and a catheter by which medication is introduced into the body of the patient. The harness is formed from elasticized fabric. The system is not suited to the delivery and collection of substances on freely ambulatory field animals left unsupervised for an extended period.
The delivery of substances to living non-human animals has commonly involved injections or devices requiring surgical implantation or retention within a natural body cavity, for example, the rumen or the vagina. The administration of substances by injection often causes abscesses and high levels of the substances are frequently found at the injection site at slaughter. Injections also can damage the hide and are therefore restricted to particular sites, e.g. to the neck region. Many drugs do not achieve their maximum therapeutic action through conventional injection techniques. The therapeutic action of such drugs is improved considerably when delivered at a controlled rate to maintain optimum drug concentration for a specific period. In a typical drug injection, a greater drug concentration than necessary must be administered to keep the drug concentration within the effective therapeutic margin for the minimum period necessary for treatment. With controlled drug infusion, the drug can be given at a precise rate that will keep the drug serum concentration above a therapeutic minimum and below toxic levels. Many drugs reach their fill potential effectiveness only through precise delivery over extended periods of time.
In animal husbandry the administration of drugs to animals involves a great deal of handling which is laborious for the handler and stressful for the animals. Often animals must be brought in from long distances making prolonged or frequent treatment difficult if not prohibitive. In some cases the stress levels caused by handling stock can impair the performance of the treatment, this is particularly true in deer. Many drugs are given in slow release capsules that can cause problems when still remaining in the animal at slaughter.
Many formulations are designed for long release to reduce stock handling requirements but concentrations often fall below the effective therapeutic levels long before the next dose is administered thus increasing the risk of drug resistance. Bacterial drug resistance is a growing problem that affects both animals and humans and commonly arises from the ineffective administration of drug treatments. Parasite drug resistance is now a major problem particularly with anti-parasite drugs such as anthelminthics.
Devices for implantation or insertion require a means for releasing the substance into the body. This may be by controlled diffusion or by the action of a pump. Some devices incorporating pumps use a battery as a power source linked to the pump via simple electronic circuitry. Difficulties arise when internally located devices, such as surgically implanted or intra-ruminal devices, remain in animals at slaughter.
One application of such devices has been the control of the timing of oestrus of domestic animals.
U.S. Pat. No. 3,499,445 discloses the blocking of oestrus by the surgical implantation of a pellet containing a hormonal medicament, and the subsequent initiation of oestrus by the subsequent surgical removal of the pellet.
There are many disadvantages in techniques requiring surgical implantation of substance delivery devices. The device requires surgical intervention for implantation and for removal of the device. There is limited control over dose timing and dose rate. There is no interruption of the dose or variation of the dose substance without surgical intervention. There is no indication of satisfactory operation of the device and no monitoring of physiological or other animal parameters. Substances cannot be collected from the animal. There is a wide variation in the uncontrolled rate of delivery of the substance, and the volume of material that can be delivered is limited by the size of the surgical implant.
Many drug treatments on firs require the sequential and accurately timed delivery of more than one substance to achieve the desired result. This is particularly true of hard to breed stock that require treatment with up to three hormones in a precisely timed delivery programme to effect oestrus. These types of treatment require frequent visits by the veterinarian and are therefore normally reserved for valuable stock.
Some cattle problems such as facial eczema are treated with daily drenches of minerals in low amounts. This is difficult enough with dairy or milking stock but is a particular problem for dry stock, which must be yarded each day.
WO 96/00106 discloses an implantable drug delivery pump system including a sensor, a pump controller, pumps and delivery systems, all preferably implanted within a body. The pumps deliver a controlled volume or a controlled rate of two or more substances, e.g. an agent and counter-agent, to the body, in response to a body condition sensed by the sensor, e.g. temperature, pressure or the presence of glucose or other constituents. The pumps are preferably electrically controlled and may be any conventionally known pump, e.g. piston, peristaltic or centrifugal.
WO 94/01165 discloses a medication-administering device in the form of a xe2x80x98smartxe2x80x99 capsule for introduction into a body cavity. The capsule is said to be particularly suited to being taken orally, but may form a suppository for taking other than orally, or may be surgically introduced to a body. The capsule casing is insoluble in body cavity fluids and contains a reservoir containing the medication which is expelled into the body cavity by a pump driven by an electrolytically-generated gas. A microprocessor controls the rate of delivery of the medication which may be varied in response to body conditions, eg pH, temperature, sound or moisture, monitored by sensors included in the capsule. An electrolytic cell co-operates with body fluids surrounding the capsule to generate electrical power to supply the microprocessor and the gas generator. The capsule may also include a radio transceiver enabling the location of the capsule to be monitored, or the operation of the capsule to be controlled, from outside the body.
The insertion of a device completely within a body cavity imposes several limitations and difficulties. The size of a device is limited by the size of the body cavity of the animal within which it is to be inserted. The dimensions of any retaining means are also limited by the size of the body cavity. The size of any batteries required, and therefore the length of time over which the device may be expected to operate, is also limited The quantity of substance that can be delivered or collected is also limited by the dimensions of the cavity into which the device is to be inserted.
Other problems of inserted devices relate to materials which are incompatible or at least undesirable for use within an animal body: e.g. lithium batteries.
Such substance delivery devices also require a means for retaining the device within the cavity of the animal. Without a reliable retention means, the device may be expelled by the animal or may simply fall out.
A device inserted into body cavities may be subject to natural muscular actions, e.g. peristalsis, tending to expel the device. This can cause problems with retention of devices. It is therefore desirable that systems provide confirmation that they remain inserted and correctly located Known methods of retaining devices in body cavities include compressible helical coils, flexible lobes or arms which can splay outwardly from the device once the device is inserted within the body cavity, and distensible ribs which can be distended by plunger action once the device has been inserted. When extended, the projections engage the cavity walls to assist in retention of the device.
WO 96/29025 discloses an apparatus for retaining a substance delivery device in a body cavity, eg intravaginal and intranirninal devices for domestic animals such as cows. The apparatus has multiple flexible arms which splay outwardly after insertion into a body cavity to retain the apparatus therein. The arms are said to bend without breaking in response to peristaltic waves within the cavity and to return to their fully extended position once peristaltic waves have passed. The delivery device is said in one embodiment to include a battery which powers piezo pumps, preferably three, for delivering substances contained in reservoirs, under control of a microprocessor. A possible application, in which the apparatus dispenses different doses of different hormones over predetermined times to positively define the date of oestrus, is disclosed. Also disclosed is the possibility that the microprocessor makes a determination of one or more physiological parameters monitored by one or more sensors, e.g. temperature, acidity viscosity and odor, before controlling the timing or the amount of a delivery of a substance to the body.
The volume of material that can be delivered by this device is limited by the volume that can be accommodated in the body cavity. NZ 207341 is a further example disclosin, a device not requiring surgical insertion into a body cavity of an animal and which produces a controlled rate of release into the body, of leachable chemicals incorporated into the device. NZ 207341 discloses a device having a spine with two resiliently hinged legs biased into a splayed disposition in which the device is T-shaped. With the legs folded together, the device may be inserted into the body cavity. A coating on the spine incorporates a chemical which leaches out when exposed to body fluids.
The device of NZ 207341 does not provide for control of the timing or rate of substance delivery or of the substance delivered. It provides no indication of satisfactory operation of the device. It does not monitor physiological or other parameters. It cannot collect substances. There is a wide and uncontrolled variation in the rate of delivery of a substance, and the volume of material to be delivered is limited by the volume that can be incorporated into the coating on the device which it self must be accommodated within a body cavity.
In devices employing outwardly-extending finger-like projections to engage the walls of a body cavity, the projections can interfere with the flow of normal body secretions. Where a device is implanted in a vaginal cavity, the projections can impair the flow of vaginal mucous. The fingers operate by pressing outwardly on the vaginal walls, holding them apart. This impairs the normal peristaltic action, retarding the normal mucous flow, and provides a void which allows an undesirable build-up of mucous around the device. The build-up of mucous often becomes infected and can interfere with the release of therapeutic material from the device and its uptake by the body.
In WO93/02634 there is described a device for artificial insemination of sows. The device is made up of a frame consisting of two hoops and a spinal column fitted over the back of a sow with a holder for a sperm tube. There is a small extension of the sperm tube extending into the vagina. The extension does not have a locator which is retained in a predetermined position within the vagina and it is possible that in the process of insemination seminal fluid in the sperm tube may well be lost or not delivered within the vagina.
Intravaginal devices often do not provide an outwardly available indication providing confirmation of the continuing presence of tie device in situ, or of its correct operation.
It is an object of this invention to go some way towards overcoming these disadvantages or at least to offer the public a useful choice.
Accordingly, the invention may be said broadly to consist in an apparatus for transporting a fluid through a natural orifice of an animal between a reservoir and a natural body cavity of said animal which comprises:
a reservoir for such fluid,
a locator at least a part of which is adapted to pass through a natural orifice and be fitted and retained within a predetermined position within said body cavity,
a conduit communicating between said reservoir and said part of said locator,
means for advancing said fluid through said conduit between said reservoir and said body cavity, and
means to secure said apparatus to said animal.
Preferably said reservoir has two or more compartments and said conduit consists of either two passages or means to deliver alternatively different fluids therethrough.
Preferably said reservoir comprises a replaceable cartridge or cartridges.
Preferably said part of said locator includes an orifice and a portion of said conduit is integral with said locator and communicates with said locator orifice.
Preferably said part of said locator is adapted to be fitted in said cavity by the provision thereon of penetration controlling means.
Preferably said penetration controlling means is adapted to engage body surfaces of said animal.
Preferably said penetration controlling means is adapted to restrain over-penetration of said part of said locator beyond said predetermined position in said cavity.
Preferably said part of said locator is adapted to be retained in said body cavity by the provision thereon of external retaining means.
Preferably said external retaining means is integral with said penetration controlling means.
Preferably said part of said locator which is adapted to pass through a natural orifice of said body cavity and be fitted for retention at a predetermined position within said body cavity is elongate and without any lateral arms or lateral extensions.
Preferably said locator is made of stiff but flexible material.
In one alternative said means for advancing said fluid is gravity.
In another embodiment said means for advancing said fluid is a pump.
Preferably said pump is provided with metering means.
Preferably said apparatus includes a microprocessor for controlling the operation of said pump.
Preferably said apparatus includes detecting means associated with said microprocessor.
Preferably said detecting means are associated with said locator.
Preferably said microprocessor is programmable to control said pump to transfer a predetermined amount of fluid at a time and in a volume determined by signals from said detecting means.
Preferably said reservoir, pump and microprocessor are located in the same housing.
Preferably said locator shaft is curved to conform to the shape of said cavity.
Preferably said microprocessor is programmable to deliver a predetermined amount of fluid at a time and in a volume determined by signals from said sensor.
Preferably said apparatus is adapted to deliver said fluid from said reservoir to a particular site in said cavity.
In an alternative embodiment said apparatus is adapted to deliver said fluid from said body cavity to said reservoir.
Preferably said means to secure said apparatus to a said animal where said animal orifice is rearward facing and said animal is a quadruped includes a first strap adapted to extend in use transversely around the body of said animal and a second strap adapted to extend in use longitudinally rearwardly therefrom along the back of said animal and encircle the proximal end of its tail.
Preferably there is provided a pouch on said second strap for receiving said reservoir and said advancing means.
Preferably there is provided a broadened flexible but stiff portion in said first strap adapted to assist in use in retaining said apparatus on said animal.
In one embodiment said external retaining means is attached to said second strap.
Alternatively said external retaining means is secured with an adhesive to the body of said animal.
In another embodiment said apparatus is adapted to be fitted to the head of an animal, said locator being adapted to be fitted and retained in its mouth.
In another embodiment said apparatus is adapted to be fitted to the head of an animal, said locator being adapted to be fitted and retained in its nasal passage.
In one embodiment of head mounted apparatus said reservoir is mounted in a position above the end of said conduit remote from said reservoir.
In another embodiment the invention may be said broadly to consist in a method for transporting a fluid between a reservoir and a natural orifice into a natural body cavity of an animal which comprises the steps of securing an apparatus as defined herein immediately above with a par of said locator inserted through a natural orifice of said body cavity into said body cavity and operating said apparatus to transfer said fluid between said reservoir and a predetermined site in said body cavity.
Preferably said animal is a quadruped
Preferably said cavity is a vaginal cavity.
Preferably said cavity is a buccal cavity.
Preferably said cavity is a nasal cavity.
Preferably said part of said locator is retained at said predetermined position within said body cavity by engagement of said retaining means with body surfaces of said animal.
Preferably said apparatus is operated to deliver fluid from said reservoir to said body cavity.
Preferably said apparatus is operated to deliver fluid from said body cavity to said reservoir.
In another embodiment the invention consists in a method of controlling the onset of oestrus of a female animal which comprises the steps of securing to said animal an apparatus as defined above with said part of said locator inserted into a natural body cavity of said animal and operating said apparatus to deliver an oestrus-controlling hormonal fluid from said reservoir to said body cavity.
Preferably said apparatus includes detecting means and indicating means, including the steps of operating said detecting means to detect an oestrus-related parameter and operating said indicating means to provide an indication of an oestrus-related state in response to said detected oestrus-related parameter.
In another embodiment the invention consists in a locator comprising a shaft portion adapted to be inserted through a natural orifice into a natural cavity of an animal to sit in a predetermined position,
said shaft portion being to self locate in said natural cavity at said predetermined position and
external retaining means adapted to maintain said shaft portion at said predetermined position in said cavity.
Preferably said shaft portion is shaped to conform to the interior shape of said body cavity without distorting said cavity.
Preferably said retaining means is attachable to said animal.
Preferably said shaft portion is adapted to self locate by the provision of penetration control means at a proximal end of said shaft, said penetration control means in use engaging an outer surface of said animal at or adjacent said animal orifice.
Preferably said penetration control means includes a lateral extension at a proximal end of said shaft portion.
In another embodiment said lateral extension extends substantially in a single direction transverse to said shaft portion.
In a further embodiment said lateral extension extends substantially in two mutually opposite directions transverse to said shaft portion.
Preferably there is included a sensor associated with said locator to sense a condition in said animal.
Preferably there is included an integral reservoir and fluid advancing means associated therewith.
The invention also consists in a method for providing a veterinary service through a natural body orifice of a natural cavity of an animal which comprises inserting the shaft portion of a locator as defined above through said orifice into said cavity in a predetermined position and providing said veterinary services using said locator.
Preferably the retaining means of said locator is attached to the exterior of said animal.
In one alternative said veterinary service is the detection of a condition in said animal.
Alternatively said veterinary service is the delivery of a fluid to said cavity.
Alternatively said veterinary service is the delivery of seminal fluid and said body cavity is a vagina.
Alternatively said veterinary service is the extraction of a fluid from said body cavity.